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Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
docetaxel, cisplatin, fluorouracil
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Phase 2 Clinical Trial, NPC, neoadjuvant chemotherapy, concurrent chemoradiation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
  • Stage ⅣAB disease
  • KPS >70
  • Age between 18-70
  • Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
  • No prior radiation treatment to the head and neck or any prior chemotherapy
  • Patients with no prior malignancy (not include basal cell carcinoma of skin)

Exclusion Criteria:

  • Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
  • Prior radiotherapy to the head and neck region for any reason.
  • Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
  • Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
  • Pregnant women

Sites / Locations

  • Department of Radiation Oncology, Cancer Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of three cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

distant metastases free survival, and disease-free survival

Full Information

First Posted
January 2, 2009
Last Updated
January 2, 2009
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT00816816
Brief Title
Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma
Official Title
Phase ⅡStudy of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to determine the tolerance and overall survival in patients with stage ⅣAB NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation. Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage ⅣAB treated with this regimen
Detailed Description
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never been defined. In the present trail, we hope to assess the tolerance and survival benefits of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage ⅣAB NPC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Phase 2 Clinical Trial, NPC, neoadjuvant chemotherapy, concurrent chemoradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of three cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
Intervention Type
Drug
Intervention Name(s)
docetaxel, cisplatin, fluorouracil
Intervention Description
neoadjuvant chemotherapy: docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. concurrent chemotherapy:cisplatin 40 mg/m2 weekly.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 and 5 years
Secondary Outcome Measure Information:
Title
distant metastases free survival, and disease-free survival
Time Frame
3 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx. Stage ⅣAB disease KPS >70 Age between 18-70 Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min. No prior radiation treatment to the head and neck or any prior chemotherapy Patients with no prior malignancy (not include basal cell carcinoma of skin) Exclusion Criteria: Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. Prior radiotherapy to the head and neck region for any reason. Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Kong, MD
Phone
8621-64175590
Ext
3900
Email
konglinj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Kong, MD
Organizational Affiliation
Department of Radiation Oncology, Cancer Hospital, Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chaosu Hu, MD
Organizational Affiliation
Department of Radiation Oncology, Cancer Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Yuan
Phone
8621-64175590
Ext
6511
Email
skelly_sh@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma

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